UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030367 |
|---|---|
| Receipt number | R000034663 |
| Scientific Title | A randomized controlled trial of the effect of coaching for low back pain over the Internet |
| Date of disclosure of the study information | 2017/12/12 |
| Last modified on | 2017/12/12 08:57:58 |
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Basic information
Public title
A randomized controlled trial of the effect of coaching for low back pain over the Internet
Acronym
A randomized controlled trial of the effect of coaching for low back pain over the Internet
Scientific Title
A randomized controlled trial of the effect of coaching for low back pain over the Internet
Scientific Title:Acronym
A randomized controlled trial of the effect of coaching for low back pain over the Internet
Region
| Japan |
Condition
Condition
Low back pain
Classification by specialty
| Psychosomatic Internal Medicine | Orthopedics | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To reveal the effectiveness of coaching for low back pain with a smartphone or personal computer.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
degree of low back pain
Key secondary outcomes
health related productivity (presenteeism)
quality of life
fear avoidance beliefs
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom | Maneuver |
Interventions/Control_1
coaching by physical therapist(twice a month/3 months)
educate how to stretch training by movies
record the degree of pain(daily)
Interventions/Control_2
Nothing
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
the persons who have low back pain
Key exclusion criteria
the persons who visit the hospital regularly for low back pain
the persons who have a history of surgery for low back pain
the persons who is pregnant
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tomohisa Nagata |
Organization
University of Occupational and Environmental Health
Division name
Institute of Industrial Ecological Sciences
Zip code
Address
1-1 Iseigaoka, yahatanishi-ku, Kitakyushu, 807-8555 Fukuoka, Japan
TEL
+81-93-603-1611
tomohisa@med.uoeh-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tomohisa Nagata |
Organization
University of Occupational and Environmental Health
Division name
Institute of Industrial Ecological Sciences
Zip code
Address
1-1 Iseigaoka, yahatanishi-ku, Kitakyushu, 807-8555 Fukuoka, Japan
TEL
+81-93-603-1611
Homepage URL
tomohisa@med.uoeh-u.ac.jp
Sponsor or person
Institute
University of Occupational and Environmental Health
Institute
Department
Personal name
Funding Source
Organization
Collabo-Health Study Group
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 12 | Month | 12 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2017 | Year | 06 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 09 | Month | 01 | Day |
Date of closure to data entry
| 2018 | Year | 10 | Month | 01 | Day |
Date trial data considered complete
| 2018 | Year | 11 | Month | 01 | Day |
Date analysis concluded
| 2018 | Year | 12 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 12 | Month | 12 | Day |
Last modified on
| 2017 | Year | 12 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034663
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
